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1 Indications The Valiant Thoracic with the Captivia Delivery System is intended for the endovascular repair of fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy, including: IIiac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; Non-aneurysmal aortic diameter in the range of 1 42 mm; and Non-aneurysmal aortic proximal and distal neck lengths 2 mm Contraindications The Valiant Thoracic with the Captivia Delivery System is contraindicated in: Patients who have a condition that threatens to infect the graft. Patients with sensitivities or allergies to the device materials. Warnings and Precautions The long-term safety and effectiveness of the Valiant Thoracic with the Captivia Delivery System has not been established. All patients should be advised that endovasculartreatment requires lifelong, regular follow-up to assess the integrity and performance of the implanted endovascular stent graft. Patients with specific clinical findings (for example, enlarging aneurysm, endoleaks, migration, or inadequate seal zone) should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructions for Use. The Valiant Thoracic with the Captivia Delivery System is not recommended in patients who cannot undergo, or who will not be compliant with, the necessary preoperative and postoperative imaging and implantation procedures as described in the Instructions for Use. Strict adherence to the Valiant Thoracic sizing guidelines as described in the Instructions for Use is expected when selecting the device size. Sizing outside of this range can potentially result in endoleak, fracture, migration, infolding, or graft wear. The safety and effectiveness of the Valiant Thoracic with the Captivia Delivery System has not been evaluated in some patient populations. Please refer to the product Instructions for Use for details Adverse Events Potential adverse events include, but are not limited to access failure, adynamic ileus, allergic reaction (to contrast, antiplatelet therapy, stent graft material), amputation, anaesthetic complications, aneurysm expansion, aneurysm rupture, angina, arrhythmia, arterial stenosis, atelectasis, blindness, bowel ischemia, bowel necrosis, bowel obstruction, branch vessel occlusion, breakage of the metal portion of the device, buttock claudication, cardiac tamponade, catheter breakage, cerebrovascular accident (CVA)/stroke, change in mental status, coagulopathy, congestive heart failure, contrast toxicity, conversion to surgical repair, death, deployment difficulties/failures, dissection/perforation/ rupture of the aortic vessel and/or surrounding vasculature, embolism, endoleak(s), excessive or inappropriate radiation exposure, extrusion/erosion, failure to deliver stent graft, femoral neuropathy, fistula (including aortoenteric,arteriovenous, and lymph), Gastrointestinal bleeding/complications, genitourinary complications, hematoma, hemorrhage/bleeding, hypotension/hypertension, infection and/or fever, insertion and removal difficulties, intercostal pain, intramural hematoma, leg/foot edema, lymphocele, myocardial infarction, neuropathy, occlusion venous or arterial, pain/reaction at catheter insertion site, paralysis, paraparesis, paraplegia, paresthesia, peripheral ischemia, peripheral nerve injury, pneumonia, post-implant syndrome, procedural/post-procedural bleeding, prosthesis dilatation/infection/rupture/thrombosis, pseudoaneurysms, pulmonary edema, pulmonary embolism, reaction to anaesthesia, renal failure, renal insufficiency, reoperation, respiratory depression/failure, sepsis, seroma, shock, spinal neurological deficit, stent graft migration/misplacement/occlusion/ twisting/kinking, transient ischemic attack (TIA), thrombosis, tissue necrosis, vascular ischemia, vascular trauma, wound dehiscence, wound healing complications, and/or wound infection. Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. MRI Safety and Compatibility Non-clinical testing has demonstrated that the Valiant Thoracic is MR Conditional. It can be scanned safely in both 1.5 T & 3. T MR systems under certain conditions as described in the product Instructions for Use. For additional information regarding MRI please refer to the product Instructions for Use. Medtronic Vascular, Inc Unocal Place Santa Rosa, CA 9543 USA Product Services Support Center Tel: Fax: CardioVascular LifeLine Customer Support Tel: Tel: UC212247a EN Medtronic, Inc All Rights Reserved. For distribution in the USA only. Innovating for life.
2 ADVANCED DESIGN The Valiant Captivia system leverages Medtronic s 13 years of thoracic stent graft experience and innovation. Our advanced design enhances confidence and is proven in more than 4, implants. * Peak FreeFlo Configuration Evenly distributes radial force over multiple apices 2. Figur Markers Platinum iridium markers provide high visibility 4 3. Enhanced Conformability Absence of longitudinal bar allows for enhanced flexibility and kink resistance * Test data on file at Medtronic, Inc. Bench test results may not be indicative of clinical performance. 4. Broad Selection of Pieces Broad selection of proximal and distal components leads to many combinations to customize for a variety of patients 2 Valiant thoracic stent graft WITH THE Captivia Delivery System 3
3 confidence in control The Valiant Captivia system features tip capture of the proximal stent. Tip capture provides controlled deployment and placement when navigating the thoracic aorta. CONTROLLED DEPLOYMENT WITH TIP CAPTURE 1. Tip Deployment 2. Tip Capture 3. Tip Release PLACEMENT RELEASE Tip capture provides accurate stent graft placement After tip capture is released, Valiant conforms to the patient s anatomy 4 Valiant thoracic stent graft WITH THE Captivia Delivery System 5
4 CONFORMABILITY DELIVERED The Valiant Captivia system is designed to conform to the thoracic aorta. The sinusoidal shape and placement of the nitinol springs provide flexibility and conformability to the anatomy. Super-elastic nitinol springs exert active radial force enhancing seal and conformability. LACK OF APPOSITION Angular flexibility & radial strength give the Valiant Captivia stent optimal seal ANGULATION RELAY ZENITH TX TAG VALIANT Results: The Valiant stent graft remained apposed to the aortic wall at each increment of neck angulation and degree of oversizing in simulated environment. For the other stent grafts tested, lack of device wall apposition was observed between the proximal anchorage segment and the inferior aortic wall. PRE Preprocedure CT image of patient in VALOR II US PMA trial Ludovic Canaud, Pierre Alric, Martrille Laurent, Thierry-Pascal Baum, Pascal Branchereau, Charles Henri Marty-Ané, and Jean-Phillipe Berthet (2) Fixation of Thoracic -s as a Function of Oversizing and Increasing Aortic Arch Angulation in Human Cadaveric Aortas. Journal of Endovascular Therapy: June 2, Vol. 15, No. 3, pp POST RADIAL FORCE (lbf) Radial Force RELAY VALIANT ZENITH TX2 TAG PROXIMAL SEALING ZONE Test data on file at Medtronic, Inc. ; 27; bench test results may not be indicative of clinical performance. Postprocedure image of one-year patient follow-up in VALOR II US PMA trial 6 Valiant thoracic stent graft WITH THE Captivia Delivery System 7
5 OPTIMIzED ACCESS The Valiant Captivia system features a crossing profile similar to or lower than other thoracic stent grafts. Ease of access means control at every step, across a broad range of anatomies. Hydrophilic coating to facilitate stent graft delivery Tip Capture Release Handle Simple turn-and-pull motion for tip release EASY THREE STEP DEPLOYMENT PROCESS AVAILABLE PROXIMAL GRAFT DIAMETERS * Medtronic Valiant Captivia Step 1. Slow, controlled deployment for precise stent graft placement Step 2. Quick deployment option if desired Step 3. Tip capture release Gore TAG Cook Zenith TX * Per device IFU Valiant thoracic stent graft WITH THE Captivia Delivery System 9
6 Component placement guide ~12 mm Peak FreeFLO Straight ( component) mm closed web Straight (distal component) 1 25 mm mm closed web tapered (distal component) mm mm Distinct radiopaque markers Figur marker Zer marker DISTAL BArE SPRING STRaight (distal component) mm ~12 mm Peak Valiant captivia product codes PROXIMAL FREEFLO STRAIGHT VAMF C 1 TU VAMF C 1 TU VAMF C 1 TU VAMF 2 2 C 1 TU VAMF 3 3 C 1 TU VAMF C 1 TU VAMF C 1 TU VAMF C 1 TU VAMF 3 3 C 1 TU VAMF 4 4 C 1 TU VAMF C 1 TU VAMF C 1 TU VAMF C 1 TU VAMF C 15 TU VAMF C 15 TU VAMF C 15 TU VAMF 2 2 C 15 TU VAMF 3 3 C 15 TU VAMF C 15 TU VAMF C 15 TU VAMF C 15 TU VAMF 3 3 C 15 TU VAMF 4 4 C 15 TU VAMF C 15 TU VAMF C 15 TU VAMF C 15 TU VAMF 3 3 C 2 TU VAMF C 2 TU VAMF C 2 TU VAMF C 2 TU VAMF 3 3 C 2 TU VAMF 4 4 C 2 TU VAMF C 2 TU VAMF C 2 TU VAMF C 2 TU DISTAL BARE SPRING STRAIGHT VAMC B 1 TU VAMC B 1 TU VAMC B 1 TU VAMC 2 2 B 1 TU VAMC 3 3 B 1 TU VAMC B 1 TU VAMC B 1 TU VAMC B 1 TU VAMC 3 3 B 1 TU VAMC 4 4 B 1 TU VAMC B 1 TU VAMC B 1 TU VAMC B 1 TU CLOSED WEB STRAIGHT VAMC C 1 TU VAMC C 1 TU VAMC C 1 TU VAMC 2 2 C 1 TU VAMC 3 3 C 1 TU VAMC C 1 TU VAMC C 1 TU 24 1 VAMC C 1 TU 24 1 VAMC 3 3 C 1 TU 24 1 VAMC 4 4 C 1 TU 24 1 VAMC C 1 TU VAMC C 1 TU VAMC C 1 TU VAMC C 15 TU VAMC C 15 TU VAMC C 15 TU VAMC 2 2 C 15 TU VAMC 3 3 C 15 TU VAMC C 15 TU VAMC C 15 TU VAMC C 15 TU VAMC 3 3 C 15 TU VAMC 4 4 C 15 TU VAMC C 15 TU VAMC C 15 TU VAMC C 15 TU VAMC 3 3 C 2 TU VAMC C 2 TU VAMC C 2 TU VAMC C 2 TU 24 2 VAMC 3 3 C 2 TU 24 2 VAMC 4 4 C 2 TU VAMC C 2 TU 25 2 VAMC C 2 TU VAMC C 2 TU CLOSED WEB TAPERED VAMC C 15 TU VAMC 2 24 C 15 TU VAMC 3 26 C 15 TU VAMC 32 2 C 15 TU VAMC 34 3 C 15 TU VAMC C 15 TU VAMC 3 34 C 15 TU VAMC 4 36 C 15 TU VAMC 42 3 C 15 TU VAMC 44 4 C 15 TU VAMC C 15 TU Valiant thoracic stent graft WITH THE Captivia Delivery System 11
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